Drug Shortages: Manufacturer Accountability Increasing

FEBRUARY 23, 2017

Dylan Girardi, 2017 PharmD Candidate, the University of Connecticut

All over the world, drug shortages cause complex and risky adjustments to medical regimens. While epidemiologic data tracking shortages has only been collected since the early 2000s, the trend shows a definite increase in incidence. Shortages stem from a variety of causes including:

Manufacturing difficulties

Raw materials shortage

Recalls

Natural disasters

Business/economic pressures

The causes are well understood, but little research documents the consequences of drug shortages. Understanding how patients, providers, and health systems are affected by drug shortages can be complicated by:

Incomplete disclosure of drug shortages

Difficulties in determining inventories in real-time

Difficulties associating shortages with clinical outcomes in a population

A research group from Montreal, Quebec, Canada has studied drug shortages since 2006. In Canada, more than 1000 drugs may be affected within a single year, and most shortages last 4-5 months. In the same year, the FDA reported just 210 shortages here in the United States—although comparisons are difficult due to variable definitions of the word shortage.

In the United States and Canada, cardiovascular drugs account for 1 of the top 5 drug-class shortages. Resulting adjustments cause suboptimal drug selection, increased labor cost, errors, and poor outcomes including death.

Previous attempts to increase transparency have been unsuccessful due to voluntary reporting of data by manufacturers. New Canadian legislation requires manufacturers to give advanced notice of shortages—like in the United States—starting in 2017.

But mandatory reporting alone is not expected to solve the drug shortage problem. Researchers are calling on clinicians and government organizations to make manufacturers more accountable for drug availability and adaptation during shortages.

They recommend that hospitals create a multidisciplinary committee with a mandate to identify drug shortages and create action plans. They urge clinicians to collect and publish more data on incidents related to drug shortages so that we may understand their impact on patients better.

The researchers conclude that pharmacies must review their inventory management policies to ensure a safe buffer in case of shortages.

This article appears in the February, 2017 issue of the Canadian Journal of Cardiology.